The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 5
- 主要终点
- Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery
研究概览
简要总结
The investigators propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior post-operative analgesic efficacy as compared to current pain management in patients undergoing unilateral thoracotomy cardiac procedures.
详细描述
Completion of the proposed study will for the first time demonstrate efficacy of intercostal cryoanalgesia in patients undergoing minimally invasive cardiac procedures. Furthermore, results of this study may have a pivotal role in supporting future clinical outcome trials for intercostal cryoanalgesia therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 85 years male or female
- •Patients undergoing unilateral thoracotomy cardiac procedures (with the exception of Aortic Aneurysm repair as sole treatment)
- •Acceptable surgical candidate, including use of general anesthesia
- •Willing and able to provide written informed consent
- •Willing and able to return for scheduled follow-up visits
排除标准
- •Cardiac valve surgical procedure via conventional full sternotomy
- •Procedures that require a posterolateral thoracotomy
- •Current pregnancy
- •Current use of prescription opioids
- •FEV1 < 40% predicted
- •Documented myocardial infarction within 30 days of signing Informed Consent Form (ICF)
- •Documented psychiatric disease
- •Documented chronic pain syndrome
- •Documented history of substance abuse
- •Patient currently enrolled in another research study that could directly affect results of either study
- •Physical or mental condition that would interfere with patient's self-assessment of pain
- •Disqualifying medical condition per investigator
研究组 & 干预措施
Cryoanalgesia + Standard of Care (SOC)
Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.
干预措施: Cryoanalgesia (Device)
Cryoanalgesia + Standard of Care (SOC)
Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.
干预措施: Standard of Care (Drug)
Standard of Care
Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.
干预措施: Standard of Care (Drug)
结局指标
主要结局
Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery
时间窗: 48-hours post-surgery
Forced Expiratory Volume (FEV1) is the measurement of how much air, in volume, that a person can exhale with a forced breath. It is measured using a spirometer device.
Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery
时间窗: 48-hours post-surgery
The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically.
次要结局
- Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation(48-hours post-extubation)
- Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points(72-, 96- and 120-hours Post-Op)
- Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit(3 and 6 Months)
- Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room(Hours until patient is extubated from time patient leaves the operating room)
- Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge(Procedure to Discharge)
- Secondary Outcome 7: Ambulatory Movement During Hospital Stay(Baseline, 48, 72, 96, 120 Hours and Discharge)
- Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points(24-, 48, -96 and 120-hours)